System and method for heating the prostate gland to treat and prevent the growth and spread of prostate tumor

Abstract

Improvements in safety and efficacy for externally focused adaptive phased array microwave thermotherapy (hyperthermia) for treatment of cancer and benign conditions of an organ or an appendage are described. In order to reduce blood flow thereby accumulating additional equivalent thermal dose following the step of heating an organ or appendage by irradiating microwaves at the organ or appendage, the step of compressing the organ or appendage following the heating step is added to thermotherapy treatment. In a preferred embodiment, the organ is the prostate and periodic prostate compression is employed to reduce the prostate blood flow thereby allowing chemotherapy, thermosensitive liposome-encapsulated chemotherapy, or gene therapy to accumulate in the prostate region during thermotherapy. Doppler ultrasound imaging may be used to measure tumor blood flow rate and then serve as real-time feedback to assist in adjusting the amount of balloon catheter inflation and to assess damage to the tumor vasculature during the treatment.

We claim:  
     
       1. A method for treating tissue of the prostate comprising the steps of: 
       heating targeted prostate tissue via energy to a temperature so that the urethral and rectal walls near the prostate do not rise significantly above 41° C. for more than several minutes; and  
       compressing the prostate following the application of the energy, the energy being selected from the group comprising microwave, ultrasound, laser and energy via a fluid to reduce prostatic blood flow in order to accumulate added thermal dose in the targeted prostate tissue.  
     
     
       2. The method for treating the prostate according to  claim 1 , wherein the application of energy is achieved with a single applicator, said applicator being selected from the group comprising an implant, a transurethral applicator and a transrectal applicator. 
     
     
       3. The method for treating the prostate according to  claim 1 , wherein the compression step is achieved by inflating a balloon selected from the group comprising a transurethral catheter balloon, a transrectal balloon, and a combination of a transurethral catheter balloon and transrectal balloon. 
     
     
       4. The method for treating the prostate according to  claim 3 , further comprising the step of using real-time feedback from a doppler ultrasound velocity imaging system to adjust and verify the amount of prostate compression as a result of the transurethral and/or transrectal balloon inflation. 
     
     
       5. A method for safely administering thermotherapy, comprising the steps of: 
       applying energy selected from the group comprising microwave energy, ultrasound energy, laser energy and energy via a fluid;  
       following the application of energy selected from the group comprising microwave energy, ultrasound energy, laser energy and energy via a fluid, compressing at least one of an organ and an appendage to be treated by using one of a balloon catheter and a balloon cuff to reduce organ or appendage blood flow therein; and  
       applying therapy selected from the group comprising chemotherapy, gene therapy, thermosensitive liposomes containing chemotherapy, and radiation therapy in combination with the compression in order to treat cancer and/or a benign condition of the organ and/or appendage.  
     
     
       6. The method for safely administering thermotherapy according to  claim 5 , wherein the balloon catheter is selected from the group comprising a transurethral balloon catheter, a transrectal balloon catheter, and a combination of the transurethral balloon catheter and a transrectal balloon catheter. 
     
     
       7. The method for safely administering thermotherapy according to  claim 6 , wherein the organ being treated is the prostate and a balloon catheter is employed to compress the catheter, and further comprising the steps of adjusting the amount of prostate compression and verifying the amount of prostate compression as a result of the transurethral and/or transrectal balloon catheter. 
     
     
       8. The method for safely administering thermotherapy according to  claim 7 , wherein the steps of adjusting and verifying are achieved using real-time feedback from a doppler ultrasound velocity imaging system. 
     
     
       9. The method for safely administering thermotherapy according to  claim 5 , wherein the organ is the prostate, a balloon catheter is used to compress the prostate and the compressing step of the prostate occurs after therapy selected from the group comprising chemotherapy, thermosensitive liposomes containing chemotherapy, and radiation therapy is infused into the bloodstream of a patient to deliver a therapeutic agent; said compressing step including inflating the balloon catheter thereby compressing the prostate gland for a first time period between approximately 1 minute to approximately 10 minutes, and then, after the compression of the first time period, deflating the balloon catheter to allow unrestricted blood flow into the prostate for a second time period of less than approximately 1 minute. 
     
     
       10. The method for safely administering thermotherapy according to  claim 9 , wherein the process of inflating and deflating the balloon catheter is repeated until the desired amount of therapeutic agent is delivered to the prostate. 
     
     
       11. The method for safely administering thermotherapy according to  claim 5 , wherein an appendage is to be compressed and treated for cancer and/or a benign condition. 
     
     
       12. The method for safely administering thermotherapy according to  claim 11 , wherein the appendage is one of a arm, leg or torso. 
     
     
       13. A method for effectively delivering therapy selected from the group comprising chemotherapy, thermosensitive liposomes containing chemotherapy, and gene therapy comprising the steps of applying one of chemotherapy, thermosensitive liposomes containing chemotherapy, and gene therapy to an organ or an appendage; and then modulating inflation and deflation of one of a balloon catheter and a balloon cuff about the organ or appendage to compress the organ or appendage to vary the blood flow therein. 
     
     
       14. The method for effectively delivering therapy according to  claim 13 , further comprising the step of heating tissue of the organ or tissue with energy selected from the group, comprising microwave, ultrasound, radiofrequency, and laser energy and wherein the modulating compression of the organ or appendage and thermotherapy together increase the medicinal effects of one of the delivered chemotherapy, thermosensitive liposomes containing chemotherapy, and gene therapy. 
     
     
       15. The method for effectively delivering therapy according to  claim 14 , wherein the organ being treated is the prostate. 
     
     
       16. The method for effectively delivering therapy according to  claim 14 , wherein the appendage being treated is one of an arm, a leg and a torso. 
     
     
       17. A method for effectively delivering liposomes containing chemotherapy to a prostate to be treated comprising the steps of applying energy selected from the group comprising microwave energy, ultrasound energy, laser energy and energy via a fluid to the prostate to be treated; and time-modulating balloon catheter compression of the prostate gland to reduce blood flow in the prostate thereby reducing blood flow and providing more time for liposomes containing chemotherapy to deliver chemotherapy to the prostate. 
     
     
       18. The method for effectively delivering liposomes according to  claim 17 , wherein the step of time-modulating the balloon catheter compression uses real-time feedback from a doppler ultrasound velocity imaging system to adjust and verify the amount of prostate compression. 
     
     
       19. The method for effectively delivering liposomes according to  claim 17 , wherein the compression step is achieved by inflating a balloon selected from the group comprising a transurethral catheter balloon, a transrectal balloon, and a combination of a transurethral catheter balloon and a transrectal balloon. 
     
     
       20. A method for early treatment of cancerous, pre-cancerous, or benign conditions of a prostate by irradiation of the prostate, comprising the steps of: 
       a) Determining one of the prostate specific antigen (PSA) level and the American Urological Association (AUA) Symptom Index of a patient;  
       b) compressing the prostate of the patient;  
       c) Heating the patient's compressed prostate with focused microwave energy when either the PSA level is less than 4.0 ng/ml or the AUA index is less than 13 to reduce the production of PSA in the prostate; and  
       d) Following the application of energy selected from the group comprising microwave energy, ultrasound energy, laser energy and energy via a fluid, compressing the prostate to reduce prostatic blood flow in order to accumulate added thermal dose in the prostate.